IT-tillämpningar

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document defines cyber security requirements for products with digital elements belonging to product category “application on the Smart Cards, Secure Elements, and similar devices” (hereinafter called “Product”). It extends the prEN 50764:2026, which defines the cyber security requirements for the platform underneath the application.

All products with digital elements having the form of a Smart Card or any similar device, where application is not installed on a platform defined by prEN 50764:2026 are excluded from the scope of this document.

More details about the product context in scope is given with Clause 4

The scope of this standard is to define a nomenclature for communication of information from point-of care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert identifiers for devices and systems used in acute care

The standard specifies a data model in UML and a derived XML schema (XSD) for defining the Level of Information Need in software applications based on concepts and principles given in Part 1, and guidance given in Part 2, in compliance with the principles and data exchange standards of data templates (ISO 23387). The standard defines the exchange format schema in XSD according to the UML schema and it gives guidelines for the usage and application of the schema. In addition, the integration with Linked Data principles and paradigms will be demonstrated.

This document defines a framework for assessing the quality of data governance and data management practices for participants in data spaces. It specifies the core principles, processes, and assessment elements that enable organizations to manage, monitor, and improve their data governance and data management practices. The framework comprises two components: • Process Reference Model: Defines key processes for data governance and data product management of data space participants, including its fundamental principles, structure, detailed process definitions, links to broader data governance, and required implementation measures. • Process Assessment Framework: Outlines a model to evaluate process capability by establishing six distinct quality levels expressed in terms of capability levels, describing the corresponding profiles and guiding the systematic assessment. This standard is aimed at supporting data governance and data management professionals, IT managers, quality assurance officers, and regulatory bodies. This standard is applicable to organizations of all types and sizes.

This document outlines the concepts and principles for information management at a stage of maturity described as "building information modelling (BIM) according to the ISO 19650 series". This document provides recommendations for a framework to manage information including exchanging, recording, versioning and organizing for all actors. This document is applicable to the whole life cycle of any built asset, including strategic planning, initial design, engineering, development, documentation and construction, day-to-day operation, maintenance, refurbishment, repair and end-of-life. This document can be adapted to assets or projects of any scale and complexity, so as not to hamper the flexibility and versatility that characterize the large range of potential procurement strategies and so as to address the cost of implementing this document.

This document specifies requirements for information management, in the form of a management process, within the context of the delivery phase of assets and the exchanges of information within it, using building information modelling. This document can be applied to all types of assets and by all types and sizes of organizations, regardless of the chosen procurement strategy.

This document specifies a common framework for audit trails for electronic health records (EHR), in terms of audit trigger events and audit data, to keep the complete set of personal health information auditable across information systems and domains. It is applicable to systems processing personal health information that create a secure audit record each time a user reads, creates, updates, or archives personal health information via the system. NOTE      Such audit records at a minimum uniquely identify the user, uniquely identify the subject of care, identify the function performed by the user (record creation, read, update, etc.), and record the date and time at which the function was performed. This document covers only actions performed on the EHR, which are governed by the access policy for the domain where the electronic health record resides. It does not deal with any personal health information from the electronic health record, other than identifiers, the audit record only containing links to EHR segments as defined by the governing access policy. It does not cover the specification and use of audit logs for system management and system security purposes, such as the detection of performance problems, application flaw, or support for a reconstruction of data, which are dealt with by general computer security standards such as ISO/IEC 15408 (all parts)[9]. Annex A gives examples of audit scenarios. Annex B gives an overview of audit log services.